Sotagliflozin improves time in range in basal insulin-treated type 2 diabetes
Click Here to Manage Email Alerts
Key takeaways:
- Sotagliflozin 400 mg improved time in range vs. placebo in patients with basal insulin-treated type 2 diabetes.
- Sotagliflozin 400 mg also improved other CGM-measured glucose metrics vs. placebo.
In patients with basal insulin-treated type 2 diabetes, sotagliflozin was associated with greater time in range compared with placebo at 18 weeks, researchers reported at the European Association for the Study of Diabetes Annual Meeting.
“Sotagliflozin is a dual SGLT1 and SGLT2 inhibitor that increases kidney glucose excretion and blunts or delays intestinal glucose absorption, resulting in glycemic control improvements in type 2 diabetes,” Julio Rosenstock, MD, FACE, senior scientific adviser for Velocity Clinical Research and director of Velocity’s site at Medical City Dallas and clinical professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said during a presentation. “Similarly, in people with type 1 diabetes, sotagliflozin has previously demonstrated glycemic efficacy in lowering HbA1c and improving time in range when used as an adjunct to insulin therapy in the inTandem clinical program. But no time in range has been assessed in people with type 2 diabetes given sotagliflozin.”
Rosenstock and colleagues conducted a prespecified substudy of the phase 3 SOTA-INS trial analyzing sotagliflozin (Inpefa, Lexicon) compared with placebo for time in range and other metrics of continuous glucose monitoring at 18 weeks.
The full cohort study included 571 adults with type 2 diabetes on basal insulin (most of whom were also taking oral agents) who had an HbA1c of 7.5% to 10.5%. The patients were randomly assigned 1:2:1 to sotagliflozin 200 mg once daily (mean age, 60 years; 47% women), sotagliflozin 400 mg once daily (mean age, 61 years; 50% women) or placebo (mean age, 64 years; 27% women). The continuous glucose monitoring prespecified study was conducted in 133 participants.
The placebo group did not have an increase in time in range, defined as a glucose level of 70 mg/dL to 180 mg/dL spent more than 70% of the time, during the study period (baseline, 50.5%; 18 weeks, 43.7%), but the sotagliflozin 200 mg group did (baseline, 48.4%; improved at 18 weeks to, 63.6%), as did the sotagliflozin 400 mg group (baseline, 54.7%; improved at 18 weeks to, 66.2%), Rosenstock said during the presentation.
Compared with the placebo group, the sotagliflozin 400 mg group had better mean time in range percentage (P = .05), mean time in tight range (70-140 mg/dL) percentage (P = .02) and mean change in 24-hour glucose (P = .02), as well as a trend toward better mean change in 2-hour postprandial glucose (P = .06), Rosenstock said, noting that all four metrics also trended toward favoring sotagliflozin 200 mg over placebo.
There were few changes in level 1 or level 2 hypoglycemia during the study period, he said.
“Sotagliflozin 400 mg improved time in range and several CGM parameters,” Rosenstock said during the presentation. “SGLT1 and SGLT2 inhibition with [sotagliflozin] may offer a therapeutic option to improve glucose control in basal insulin-treated type 2 diabetes who meet the [sotagliflozin] indications, which are to reduce cardiovascular risk of death and reduce hospitalization or urgent visit for heart failure in adults with established heart failure irrespective of diabetes status or in people with type 2 diabetes with chronic kidney disease or other factors."
Collapse
Hardin MB, et al. SO 059. Presented at: European Association for the Study of Diabetes Annual Meeting; Sept. 9-13, 2024; Madrid.
Click Here to Manage Email Alerts